For baseline measurement of pre-implant whole blood and serum cobalt and chromium ion levels 120 males and females who do not currently have a medical device implant and meet the inclusion/exclusion criteria will be enrolled.

Sample Size

The study population is expected to be comprised of 400 males and females who underwent metal on metal THR within the last 96 months (range 1-8 years) and meet the inclusion/exclusion criteria. Subjects will be enrolled at up to 15 clinical sites.

For baseline values of non-implantable subjects that will be used as a reference with the cross-sectional study subjects’ whole blood and serum cobalt and chromium ion levels. At the cross-sectional study sites, any non-implanted patient who is a candidate to undergo MoM THR with a Zimmer hip system will be asked to enroll in the study. A total of 120 cases are expected to be included in this study group.

Data Collection

Study endpoints include adverse events, changes in metal ion concentrations in whole blood and serum over time, radiographic results and any incidence of adverse local tissue reactions that might be linked to metal ion levels or certain patient clinical or demographic characteristics.

Follow-up Visits and Length of Follow-up

Patients will undergo a one-time cross-sectional assessment, as available by product release date (3 months - 8 years post-op).

SUI AE and Effectiveness rates
Schedule

Report Schedule

ReportDate Due

FDA ReceiptDate

Applicant's Reporting Status

6 month report

08/01/2013

08/01/2013

On Time

1 yr report

01/31/2014

01/31/2014

On Time

18 month report

08/01/2014

07/31/2014

On Time

2 yr report

01/31/2015

02/02/2015

Overdue/Received

3 yr report

01/31/2016

01/29/2016

On Time

4 yr report

01/30/2017

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Final report

06/29/2018

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The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.

In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.

CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.

In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.